N/A
Completed N=52
A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.
Source: ClinicalTrials.gov NCT03951610 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With Lens Centration — 17; 12; 34; 39 Participants
Summary
The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Lens Centration |
20; 16; 31; 36; 1; 0 | — |
| PRIMARY Post Blink Movement |
0.26; 0.25 | — |
| PRIMARY Primary Gaze Lag |
0.23; 0.22 | — |
| PRIMARY Up Gaze Lag |
0.28; 0.29 | — |
| PRIMARY Push-Up Tightness |
45; 48 | — |
| PRIMARY Overall Fit Acceptance |
3.12; 3.13 | — |
| PRIMARY Number of Participants With Overall Lens Fit Impression |
0; 1; 9; 9; 41; 41 | — |
| SECONDARY Subjective Comfort Rating |
9.1; 9.1 | — |
Eligibility Criteria
Inclusion Criteria
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
- Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
- Has no more than 0.75 diopters of refractive astigmatism.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
- Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
Exclusion Criteria
- Is presently participating in any other clinical or research study including eye related clinical or research study.
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
- Has any known sensitivity to fluorescein dye or products to be used in the study.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).
Data sourced from ClinicalTrials.gov (NCT03951610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.